Monitoring product integrity of a pharmaceutical product in a syringe using a miniaturized electronic sensor tag

ABSTRACT

The package for a pharmaceutical product includes a syringe and an electronic tag for obtaining information relating to the integrity of the product as assessed from an exposure of said product to physical or environmental conditions during a time span. The tag is attached at or to a constituent of the syringe; or at least a portion of the tag is integrated in a constituent of the syringe. The tag includes an electronics unit having a control unit, a sensor unit having at least one sensor for monitoring the physical or environmental conditions, a display unit having a display for displaying data relating to the integrity referred to as status data and a switch. The control unit is structured and configured for effecting that the display unit displays the status data in reaction to an operation of the switch.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to the field of monitoring the integrityof pharmaceutical products that are sensitive to physical orenvironmental conditions. More specifically, the present inventionrelates to the monitoring of the integrity of a pharmaceutical productin a syringe, and moreover relates to ways of estimating the integrityof a pharmaceutical product in a syringe as assessed from the exposureof the product to physical or environmental conditions up to at leastapproximately the time of its use.

Description of Related Art

When it comes to sensitive or delicate pharmaceutical products, it canbe desirable to monitor their exposure to specific hazards such asparticularly high or low temperatures, particularly high or low humidity(water-content of ambient air), or particularly strong impacts (hits,blows), so as to be able to estimate the integrity of the transported orstored goods.

It is known to use chemical indicators for estimating the temperatureexposure of a medicament. For example, a particular chemical substanceis applied onto a syringe containing a pharmaceutical product. If thatsubstance is exposed to a too high or too low temperature during a toolong time, its color is (visibly) changed. Corresponding products arecommercially available.

Furthermore, RFID tags are frequently used by transport and logisticscompanies for monitoring the integrity of various goods during theirtransport from the manufacturer of the goods to a distributor orwholesaler. Such RFID tags are, e.g., attached to a trading unit on apalette, and results of measurements carried out in the RFID tag, e.g.,temperature measurements, are wirelessly transmitted to the RFID readerin order to be evaluated and/or looked at.

SUMMARY OF THE INVENTION

One object of the invention is to create a new way of enabling a personusing a pharmaceutical product in a syringe such as a health carespecialist, to check whether or not the product is—with a highprobability—sound, in particular at the time of using the product.

Another object of the invention is to provide a simple way of enabling aperson to check the integrity of a pharmaceutical product in a syringe,in particular approximately at the time of its use.

Another object of the invention is to provide a way of enabling a personto check the integrity of a pharmaceutical product in a syringe, inparticular approximately at the time of its use, which is compatiblewith already established packaging and distribution schemes.

Another object of the invention is to provide a way of enabling a personto check the integrity of a pharmaceutical product in a syringe withoutrequiring the presence of any additional object or tool for doing so,e.g., without a reading device.

Another object of the invention is to provide a way of minimizing theprobability of fraud or deceit when it comes to proving or demonstratingan integrity status of a pharmaceutical product in a syringeapproximately at the time of its use.

Another object of the invention is to provide ways for preventing orreducing malpractice in conjunction with monitoring the integrity of asensitive pharmaceutical product in a syringe.

Another object of the invention is to provide a particularlycost-effective way monitoring the integrity of a pharmaceutical productin a syringe and/or of enabling a person to check the integrity of apharmaceutical product in a syringe.

Another object of the invention is to provide a way of manufacturing apackage for a pharmaceutical product or of a portion thereof, which hasa particularly low number of manufacturing steps.

A corresponding package for a pharmaceutical product as well as acorresponding method for monitoring an integrity of a pharmaceuticalproduct shall be provided. Furthermore a corresponding packagedpharmaceutical product, a corresponding plunger device and acorresponding tag device shall be provided as well as correspondingmethods for manufacturing a package for a pharmaceutical product, formanufacturing a tag device, and for manufacturing a plunger device.

Further objects emerge from the description and embodiments below.

At least one of these objects is at least partially achieved byapparatuses and methods according to the patent claims.

According to the present invention, a package for a pharmaceuticalproduct includes:

-   -   a syringe;    -   an electronic tag for obtaining information relating to the        integrity of the product as assessed from an exposure of the        product to physical or environmental conditions during a time        span;        wherein        I) the tag is attached at or to a constituent of the syringe; or        II) at least a portion of the tag is integrated in a constituent        of the syringe;        and wherein the tag includes an electronics unit including    -   a control unit;    -   a sensor unit including at least one sensor for monitoring the        physical or environmental conditions;    -   a display unit including a display for displaying data relating        to the integrity referred to as status data;    -   a switch;        wherein the control unit is structured and configured for        effecting that the display unit displays the status data in        reaction to an operation of the switch.

Such a package can make possible that a user who wants to use or applythe pharmaceutical product (who usually is not a person trading it ordealing with it), such as a patient or a health care specialist, can ina simple and direct way and without further education and withoutneeding further equipment or tools operate the tag and find out aboutthe integrity of the pharmaceutical product, in particular at(approximately) the time of using or applying the product. And thepackage can be very compact and cost-efficient.

The term “package” is used in a rather wide sense, as already thesyringe with attached tag is considered a package, since thepharmaceutical product to be contained in the syringe (usually in abarrel of the syringe) can be considered to be packaged thereby.However, as will become clear, the package can also be a package in anarrower and more conventional sense, such as a package including anouter package such as a cardboard box or a polymer blister inside ofwhich the syringe is present.

In the above configuration I), the tag is attached to or at aconstituent of the syringe. In this case, the constituent can be aseparate part to or at which the tag is fixed, usually by fixing atleast a constituent of the tag, such as a housing of the tag, at or tothe constituent of the syringe. The attaching may be accomplished, e.g.,by means of a bonding agent present between the respective constituentof the syringe and the respective part or constituent of the tag, or byform-fitting, e.g., wherein the part of the tag fully or partiallyencompasses the respective constituent of the syringe.

Configuration I) can be considered a “retrofit” solution. ConfigurationI) can allow to use conventional syringes for producing the package.

In the above configuration II), at least a portion of the tag (or aconstituent of the tag) is integrated in a constituent of the syringe.This may be accomplished, e.g., by providing that the portion of the tagis contained in the constituent of the syringe, or by providing that theportion of the tag establishes the constituent of the syringe or, viceversa, that the constituent of the syringe establishes a portion of thetag.

More concretely, the electronics unit or a portion thereof may becontained in a constituent of a plunger assembly of the syringe and inparticular in a plunger top of the syringe; or a housing of the tag isestablished by or establishes a constituent of a plunger assembly of thesyringe and in particular a plunger top of the syringe. For example, asingle injection molded part may house at least a portion of theelectronics unit and function as a plunger top of the syringe.

Configuration II) can be considered an “integrated” solution.Configuration II) can allow to minimize the number of assembling stepsrequired for producing the package and/or to minimize the number ofparts that have to be produced for producing the package. It may also bepossible to reduce the size of the package and/or the amount of materialrequired for producing the package when selecting configuration II).

Further details and possibilities are described below.

As is usually the case for tags for integrity monitoring, it is assumedthat the monitored pharmaceutical product is exposed to approximatelythe same physical or environmental conditions as is the tag.

The time span usually is a time span during which the product is storedor transported.

The switch usually is a user-operable switch, a human-operable switch.Suitable switches can be, e.g., electro-mechanical switches orcapacitive switches. These can be particularly cost-effective and verysmall. However, magnetic switches and inductive switches may be applied,too. The switch may render superfluous the use of (additional orexternal) tools for receiving information about the integrity of thepharmaceutical product.

The switch may, in particular, be operable by touching it, and/or it maybe operable by pressing or pushing it, and/or it may be operable byapproaching it, e.g., approaching it to less than 1 cm or less than 4mm, e.g., in case of a capacitive switch. The touching, pressing,pushing, approaching may be accomplished, e.g., with a finger.

The package may include a pressing surface for operating the syringe bypressing against the pressing surface, wherein the pressing surface isprovided by the tag. In case of conventional syringes, the pressingsurface is provided by a conventional plunger top. However, providingthat the pressing surface is a surface of the tag, it can be achievableto force an operation of the switch (and a displaying of status data)when the syringe is operated, i.e. when at least a portion of thepharmaceutical product is pressed out of the barrel by means of aplunger assembly of the syringe, as is the case when the syringe is usedfor giving a patient a shot. The pressing surface may be considered asurface provided for reducing a space available in the barrel for thepharmaceutical product by pressing against the surface. Via a plungerrod, a plunger seal will be moved inside the barrel.

The display usually is a visual display.

The displaying of the status data in reaction to an operation of theswitch is effected at least after the end of the time span. This canmake possible to review the integrity status the product had, e.g., whenthe syringe was used. It may, however be provided that the displayingthe status data in reaction to an operation of the switch is alsoeffected already before the end of the time span, as in the exampleabove. This can make possible early checks of the product integrity, inparticular before operating the syringe.

The display does usually not permanently display the status data. Thissaves energy and thus makes possible a long operation duration of thetag and thus a long shelf life of the package and the tag.

Furthermore, it can be provided that displaying the status data takesplace only in reaction to operating the switch. However, it may also beprovided that it takes place also in reaction to terminating themonitoring and thus at the end of the time span. (Termination of themonitoring may take place in reaction to breaking a breakable electricalconnection described further below and a detection of the breaking.) Andalternatively or additionally thereto, it may be provided thatdisplaying the status data takes place periodically, e.g., in regulartime intervals, the (pause) interval typically being between 1 secondand 2 minutes, in particular between 5 seconds and 30 seconds. Such an“automatic” display of the status data may take place after the end ofthe time span only or during the time span only or both, i.e. from thebeginning of the time span. Looking at the display in the right moment(or waiting for up to once the pause interval) may thus dispense withoperating the switch when the integrity status shall be checked.However, the switch may be operated in order to have the status datadisplayed.

Status data displayed after the monitoring (or measuring, or sensing)has been terminated, i.e. after the end of the time span, may bereferred to as “final” status data. In case of final data, all alarmsmay be indicated which occurred between the initial point in time atwhich monitoring began and the time of termination of the monitoring. Itis furthermore possible to provide that these “final” status data arealso displayed (even without operating the switch) when the monitoringis terminated. This makes possible an immediate check of the integritystatus. And a calculation and/or a storing step may also take place atthat time, so as to obtain these “final” status data and store them inthe tag, so as to readily have access to them later on.

If it is provided that status data may be displayed by the displayalready during the time span, e.g., in reaction to operating the switch,these status data certainly merely reflect those alarm conditions whichwere met up to that instant.

Furthermore, it is also possible to provide that in addition todisplaying status data by means of the display (or as an alternativethereto), status data can be transmitted by the tag via electro-magneticradiation in the radio-frequency (RF) range (radio-frequency radiation).

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments, the tag, in particular the electronicsunit, includes an RF receiver and an RF transmitter, or an RFtransceiver, and the control unit is structured and configured foreffecting that the status data are transmitted using the RF transmitteror the RF transceiver. This transmission of status data may be effectedin reaction to an operation of the switch and/or in reaction toreceiving, in the tag, a corresponding request signal by means of the RFreceiver or RF transceiver. An RF reading device may, this way, receivestatus data from the tag, in a contact-less fashion. This may be ofadvantage when a large number of syringes shall be examined with respectto their individual product integrity.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments, the tag includes no RFID (Radio FrequencyIdentification) responding capability. However, it is, as an alternativealso possible to provide that the tag includes RFID respondingcapability:

In one embodiment which may be combined with one or more of thebefore-mentioned embodiments except for the last-mentioned one, the tagincludes RFID (Radio Frequency Identification) responding capability.For example, the tag (in particular the electronics unit) includes an RFreceiver and an RF transmitter, or an RF transceiver. This may allow toidentify in a contactless fashion, each individual tag and thus eachindividual syringe. In this case, each tag may be provided with a uniqueidentifier, which typically would be stored in the electronics unit, andwhich can be transmitted by the tag via RF, e.g., to an RFID reader.This may allow to achieve a quick overview over a large number ofsyringes, e.g., in order to check which syringes are present (and thus,which syringes would possibly be missing).

The pharmaceutical product usually is an injectable medicament. Itusually is a liquid, e.g., an aqueous solution.

The pharmaceutical product can be, e.g., a synthetic pharmaceuticallyactive substance, a natural pharmaceutically active substance, and inparticular a vaccine. Vaccines are often very delicate and alsoexpensive, such that efforts for monitoring the integrity of vaccines insyringes can be particularly useful, in particular when the vaccines areintended for use in subtropical or tropical regions.

The pharmaceutical product can be intended for human use, but it can bealso be a pharmaceutical product for use with animals, i.e. a veterinarypharmaceutical product. The invention will mainly be described for thecase of pharmaceutical products for human use, but it is readilyunderstood how the invention applies for veterinary pharmaceuticalproducts.

In one embodiment, the syringe includes a barrel and a plunger assembly,and the tag is attached to or at the plunger assembly, more particularto or at a constituent of the plunger assembly. Alternatively, the tagcan be attached to or at the barrel. Since the barrel usually issterilized, an exposure to the sterilization procedure of the tag can beavoided by providing that the tag is attached to or at a constituent ofthe plunger assembly, in particular to a constituent which is notexposed to the sterilization procedure.

The barrel is provided for containing the pharmaceutical product.

The plunger assembly usually includes a plunger top, a plunger rod, anda plunger seal. The plunger seal (also referred to as “stopper”)constitutes one end of the plunger assembly and is provided forproviding a seal inside the barrel, so as to allow to move thepharmaceutical product out of the barrel when the plunger assembly ismoved during carrying out an injection (giving a shot to a person). Theopposite end of the plunger assembly is constituted by the plunger top.In the usual operation of the syringe, the plunger seal is moved byoperating, more particularly pressing against, the plunger top, cf. alsothe pressing surface mentioned above. The two ends of the plungerassembly are interconnected by the plunger rod.

The plunger assembly can be manufactured in a single process, it mayconstitute a unitary or integrally formed part, e.g., a single moldedpart. Optionally, a sealing body, e.g., made of a resilient material,can be provided, in addition, in order to establish or contribute toestablishing the plunger seal.

However, it is also possible to manufacture the plunger top and theplunger seal separately or to provide them initially as separate partsand interconnect them then. This can be a suitable way of avoiding anexposure of the tag to a sterilization procedure. For example, a fixtureis provided between the plunger rod and one or both of plunger top andplunger seal. The fixture may be, e.g., a bonding agent such as a glue,or a pair of corresponding inner and outer threads, or a clampingfixture. Thus, it can be provided that the plunger top is separable fromthe plunger seal, which can be accomplished, e.g., by providing aseparable connection between plunger top and plunger rod and/or betweenplunger rod and plunger seal.

In one embodiment, which may be combined with the before-mentionedembodiment, the syringe includes a barrel and a plunger assemblyincludes a plunger top, and

I) the tag is attached to or at the plunger top; or

II) at least a portion of the tag is integrated in the plunger top.

This may facilitate avoiding an exposure of the tag to a sterilizationprocedure. For example, attachment of the plunger top to the rest of thesyringe (in particular—directly or rather indirectly—to the barrel) maybe accomplished after a sterilization procedure has been carried out.Furthermore, in particular for configuration I), the shape or form ofthe plunger top may be particularly suitable for attaching a tag, inparticular a particularly miniscule tag. The tag may have an overallvolume of less than three times the volume of a battery comprised in thetag.

In one embodiment referring to the last-mentioned embodiment, the switchis structured and arranged such that operating the syringe effectsoperating the switch. This way, it can be achieved that the status dataare unavoidably displayed when the syringe is operated—at least providedthat the syringe is operated in an intended way (which is the usual wayof operating the syringe), i.e. involving pushing the plunger top orpressing (directly or indirectly) against the plunger top towards thedirection in which the plunger seal is located. Thus, when letting outan amount (usually only a small amount) of the pharmaceutical productout of the barrel prior to giving the shot (which usually is doneimmediately before giving a shot in order to remove air or other gasespossibly present in the barrel together with the pharmaceuticalproduct), the status data are displayed, such that giving the shot withan unsound (perished) pharmaceutical product can be avoided (when payingattention to the display), whereas in case the display indicates (inreaction to operating the syringe) that the pharmaceutical product isassumed to be in order, the shot can be safely given.

When starting to give a shot with the syringe, the process may beinterrupted at an early stage when the display indicates that thepharmaceutical product is (according to the monitoring results obtainedby the tag) not sound anymore.

The switch may, in particular, be arranged beyond the plunger top, itmay be arranged on a side of the plunger top facing away from theplunger rod or the plunger seal.

The tag may have an operation side from which the switch is to beoperated, and the operation side may face away from the plungerassembly. This can be the case in particular for electro-mechanicswitches and capacitive switches. The tag may be arranged such that itsoperation side faces away from the plunger rod or the plunger seal.

And the tag may have an operating direction into which the switch is tobe operated, the operating direction lying along the operation directionof the syringe, i.e. along the direction pointing along the extension ofthe plunger rod from the plunger top to the plunger seal. This can bethe case in particular for electro-mechanic switches, but, depending onthe implementation also for capacitive switches, magnetic switches andinductive switches.

It can, in particular, be provided that the tag includes a printedcircuit board (usually a flexible printed circuit board) on which theswitch is mounted, and the printed circuit board is located between theswitch and the plunger top.

The attaching the tag at or to a constituent of the syringe (cf.configuration I)) can be accomplished by, e.g., bonding, gluing, using afluidly applicable glue, using a double-faced adhesive tape, using apolymer cover foil sandwiching the tag between itself and the respectiveconstituent of the syringe and including a circumferential portionsurrounding the tag, which is bonded to the respective constituent ofthe syringe, or in another way.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments in which the tag is attached to or at theplunger top, a bonding agent is present between the plunger top and thetag. This way, the tag can be quickly and cost-effectively attached toor at the plunger top. The bonding agent may be a double-sided adhesivetape, but a glue can also be used as the bonding agent.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments in which the tag is attached to or at theplunger top, the tag includes a housing, and at least a portion of theplunger top is contained in the housing. This is another way ofattaching the tag or of fixing the tag to the plunger top. In this case,the plunger top is present inside the housing. And this may provide fora mutual fixture of tag and plunger top (or, more generally, of tag andconstituent of syringe). An additional bonding agent may be present ofnot.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments in which configuration II) may apply, theconstituent of the syringe constitutes or establishes the at least oneportion of the tag. This can enhance manufacturability of the package,e.g., by reducing the number of assembly steps and/or by reducing thenumber of parts to be manufactured. Two different functions, atag-related function and a syringe-related function can thus befulfilled by one and the same item. For example, a portion of a plungerassembly of the syringe may establish a housing of the tag. Furthermore,it may be provided that a portion of the plunger assembly contains aportion of the tag such as the electronics unit or a portion thereof.The portion of the plunger assembly may in particular include theplunger top; it may, e.g., be the plunger top, or it may be a partestablishing the plunger top and at least a portion of the plunger rod.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments in which configuration II) may apply, theconstituent of the syringe contains the at least one portion of the tag.This may simplify producing the tag and/or reduce the amount of materialrequired for producing the package. The tag or a portion thereof can beat least partially enclosed by the constituent of the syringe. Theconstituent of the syringe (e.g., a portion of a plunger assembly of thesyringe) may establish a housing for the tag or for a portion thereofsuch as for the electronics unit or a portion thereof. The portion ofthe plunger assembly may in particular include the plunger top; it may,e.g., be the plunger top, or it may be a part establishing the plungertop and the plunger rod or establishing the plunger top and a portion ofthe plunger rod.

In one embodiment which may be combined with one or more of thebefore-mentioned embodiments, the tag includes a housing including afirst and a second housing portion, which are mutually attached, inparticular they may be establishing a snap fit with one another. Thisway, e.g., the electronics unit can be readily inserted into thehousing. In addition, this may very much facilitate attaching the tag toor at the plunger top. In case the tag includes a rip strip, the housingmay include an opening through which the rip strip extends out of thehousing. The opening may, in particular, be present at a location wherethe first and a second housing portions are proximate, e.g., the openingbeing defined by one or both, the first and the second housing portion.This may facilitate assembling the package.

In particular, it may be provided that the first and second housingportions are interconnected by a folding portion. The folding portionmay allow a tilting of the first versus the second housing part, inparticular due to a resilience or elasticity of the folding part,wherein this resilience or elasticity may be due to a reduced thicknessof the folding portion with respect to adjacent regions of the first andsecond housing portions. Such a tilting can take place in a well-definedway. Thus, during manufacture and more particularly during mutuallyattaching the first and second housing portions, no particularpositioning or alignment steps have to be carried out and no particularpositioning or aligning measures have to be taken in order to ensure asafe and precise fitting together of the first and second housingportions. This greatly facilitates manufacture of the package.

In configuration I), it can, in particular, be provided that the plungertop is contained in the housing (when the first and second housingportions are fixed to each other, i.e. when the snap fit is closed whichusually means that the housing is closed). This way, an attaching of thetag to or at the plunger top may be accomplished without the need ofproviding a bonding agent between tag and plunger top.

In configuration II), it can in particular be provided that the plungertop is established by the housing of the tag. Vice versa, one could saythat the tag or a portion thereof is established by the plunger top,because the plunger top establishes the housing of the tag.

The housing may furthermore be one single unitary or integrally formedpart. It may be, e.g., one single molded part such as an injectionmolded part. It can be a continuous part. This can greatly facilitatethe manufacture of the package, since less parts need to bemanufactured, and less parts need to be assembled. In configuration II),the complete housing of the tag plus the plunger top and optionally alsoplus the plunger rod (or a portion thereof) may be a single continuous(integrally formed) part, e.g., a single molded part.

In one embodiment referring to the last-mentioned embodiment, the secondhousing portion has an opening, and a constituent of the plungerassembly, in particular the plunger rod, extends into or through theopening.

Considering Configuration I):

In a first case, the opening is fully or practically fully surrounded bymaterial of the second housing portion. The opening may thus be referredto as a hole. In this case, a mechanical fixation of the tag to theplunger top may be particularly sturdy. However, it will usually benecessary or advisable to provide that the plunger assembly includesseparately manufactured parts such as a plunger top being a partmanufactured separately from the plunger seal, such that the separatelymanufactured parts can be assembled later, namely after the opening inthe second housing portion has been slid over the plunger rod.

In a second case, the opening is a recess or groove, in particular arecess or groove allowing to sidewise insert the plunger rod into theopening. In this case, a mechanical fixation of the tag to the plungertop may be less sturdy than in the first case (provided other propertiesremain substantially identical). However, such a design of the secondhousing portion can make possible to attach the tag while the plungerassembly is attached to the barrel.

Considering Configuration II):

The opening may be fully or practically fully surrounded by material ofthe second housing portion. The opening may thus be referred to as ahole. The plunger top may constitute a housing of the tag, and a plungerrod may be introduced into the plunger top in order to be fixed to theplunger top there. As an alternative to the opening in the secondhousing portion in configuration II), the second housing part mayprovide a protrusion at which or by means of which a plunger rod may befixed to the plunger top.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments, the tag includes a housing (which may ormay not include the first and a second housing portions, cf. above, andmay or may not be integrated in the syringe), and the housing includes aflexible portion structured and arranged for interacting with theswitch. The flexible portion can be provided for making possible tooperate the switch through or across the housing. It can be deformableso as to allow to apply force to the switch via (or through) theflexible portion and/or to approach the switch more closely than withoutdeforming the flexible portion. These properties can be valuable, inparticular, in case of electro-mechanical switches and also ofcapacitive switches.

The flexible portion can be realized by providing a slit in the housingdefining the flexible portion. The flexible portion may constitute atongue in the housing, wherein the tongue substantially is the flexibleportion. The tongue has at least one free end. At another end, itusually is continuous with a further part (or with the rest) of thehousing.

The flexible portion can furthermore be realized by providing an area ofreduced material thickness (nearby the switch). If the thinness of theflexible portion enables a deformation thereof allowing to operate theswitch via the flexible portion, a provision of slits in the housing fordefining the flexible portion or a tongue may be dispensed with.

It is furthermore possible to provide a housing, which is generallyflexible or elastically deformable (e.g., due to material thicknessand/or material selection), so as to allow to operate the switch throughthe housing. In this case, the housing substantially may be identicalwith the flexible portion.

As an alternative to providing the flexible portion, it is also possibleto provide an opening in the housing providing access to the switch. Forinductive and for magnetic switches, but also for capacitive switches,it may even be completely dispensed with special provisions concerningshape or material of the housing for facilitating operating the switch.

In case a flexible portion is provided, and the housing includes theabove-described first and second housing portions, the second housingportion having the opening, it may in particular be provided that theflexible portion is provided in the first portion.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments, the tag includes a housing (which may ormay not include the first and a second housing portions, cf. above, andwhich may or may not include the flexible portion, cf. above, and whichmay or may not be integrated in the syringe), and the tag includes abattery, and the housing includes a holder for holding the battery. Inthe above-described case of a provision of the first and second housingportions, the holder may be provided in the first or in the second or inboth, the first and second housing portions.

The holder may, in particular, be or provide a clamping fixture.Clamping the battery in the housing can provide a precise andmechanically sufficiently stable alignment of the battery with respectto the housing—and thus also with respect to features of the housingsuch as openings or windows (such as windows for light emission).Furthermore, provided that the battery is mounted on a printed circuitboard (PCB), e.g., using battery leads, also that PCB and thus alsoother components mounted on the PCB are aligned with respect to thehousing. Typically, a single PCB is provided that is included in theelectronics unit and on which also all other components of theelectronics unit are mounted such as LEDs or other display componentsand a controller chip, one or more capacitors and the like. The one PCBmay (cf. below) also establish the rip strip, if present.

The holder and/or the clamping fixture may include, e.g., one or moreprotrusions or ribs present inside the housing.

The battery is usually provided for powering other constituents of theelectronics unit.

Instead of a battery, one could also provide a different storage unitfor providing electric energy.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments, the tag includes a printed circuit board(PCB) for interconnecting components of the electronics unit. Inparticular, the PCB is a flexible PCB, e.g., based on a polymer foil. Itmay be identical with or continuous with a rip strip of the tag (ifpresent).

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments, the tag includes a rip strip including abreakable electrical connection operationally connected to the controlunit. The rip strip can be used for indicating (to the control unit) theend of the time span, or for indicating (to the control unit) thebeginning of the time span, or for both. This may be accomplished, e.g.,by suitably cutting the rip strip.

It is usually provided that when the rip strip is ripped (in a suitableplace), the electrical connection is broken, e.g., because one or moreconductor lines (in particular a conductor line loop) of the rip stripis interrupted. This can be detected by the control unit, e.g., bysensing an increase of an ohmic resistance. It may be an indication ofan end of the time span, and thus, the monitoring can be terminated inreaction thereto.

The rip strip usually is a flat member (its extension in a firstdimension being clearly smaller than in the other two) and has anelongated shape (its extension in a second dimension being smaller thanin the third dimension). The breaking of the electrical connectionusually takes place by dividing (cutting, tearing apart) the rip stripgenerally along the second dimension.

In one embodiment referring to the last-mentioned embodiment, the ripstrip includes or essentially is a printed circuit board (PCB). It may,in particular, include or essentially be a flexible printed circuitboard. And more particularly it may include or essentially be a foil inand/or on which at least one conductor line is present, which isoperationally connected to the control unit. The at least one conductorline forms or establishes the breakable electrical connection and itmay, in particular, describe a loop. The foil may, in particular, be anelectrically insulating polymer foil. The (usually flexible, butpossibly rigid) PCB of the rip strip may be continuous with a PCB of theelectronics unit.

It may be provided that the rip strip includes a foil and, present onthe foil, at least one conductor line operationally connected to thecontrol unit. In particular, the at least one conductor line may form orestablish at least one loop. Typically one or two loops, perhaps threeare provided. Each loop may constitute one breakable electricalconnection. In case of a single loop, the interruption thereof usuallywill indicate that the product is about to be accessed and/or indicatethat the end of the time span has come (and the monitoring isterminated). In case of two loops, the first is like thebefore-described single one, and the interruption of the second loopusually will indicate that the product is about to be packaged (or hasjust been packaged) and/or indicate the beginning of the time span (andthus the start of the monitoring). In case of three loops, yet anotherfunctionality may be added to those of the before-described ones.

It is noted that instead of (or in addition to) terminating the timespan by ripping a rip strip of the tag, a functionality (provided by thecontrol unit) can be provided that the monitoring is terminated inreaction to an operation of a switch, which we shall refer to asterminating switch. That terminating switch may be identical with ordifferent from the switch (“display switch”) for effecting thedisplaying of the status data (if present). If the switches areidentical, different effects may be provoked by differently operatingthe switch. For example, a brief operation of the switch (e.g., for atmost 1 or 1.5 seconds) provokes a displaying of the status data, whereasa longer operation (e.g., for more than 8 seconds) effects a terminationof the monitoring. It is furthermore possible to provide a single switchthat fulfills at least three different functions accessible bydifferently operating the switch. These functions may in particular be:starting the monitoring; terminating the monitoring; requesting adisplaying of the status data (usually during the whole time span andthereafter, too, namely then displaying the “final” status data, cf.below for details of the “final” status data). The different ways ofoperating may be operating the switch for time durations in differentnon-overlapping time duration intervals. For example, operating theswitch for less than 2 seconds is interpreted by the control unit as arequest for displaying status data, operating the switch for a durationbetween 3 and 6 seconds is interpreted by the control unit as a requestfor starting the time span (and thus the monitoring), and operating theswitch for more than 9 seconds is interpreted by the control unit as arequest for ending the time span and thus terminating the monitoring.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments, the package includes an outer package inwhich the syringe and the tag are contained. The outer package may be acardboard box and more particularly a folding carton. It is alsopossible to provide an outer package substantially made of a polymer,e.g., a blister-type or bag-type polymer package—which usually isair-tight. It is also possible to provide a two-level outer package suchas a cardboard box containing a polymer package, e.g., of thebefore-described kind, which again contains the syringe and the tag.

In one embodiment referring to the last-mentioned embodiment, in theouter package, no further syringe is contained in addition to thebefore-mentioned syringe.

Similarly:

In one embodiment which may be combined with one or more of thebefore-mentioned embodiments, the package includes no further syringe inaddition to the before-mentioned syringe.

For packages reaching the end user, it is usually meaningful to provideno more than only one single syringe per package. However, one or moreadditional containers containing further pharmaceutical products such astwo vials with different vaccines may be present in the package, too.

In one embodiment which may be combined with one or more of thebefore-mentioned embodiments, the display unit is structured andconfigured for displaying the status data by flashing. In other words,the status data are encoded in flashing.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments, the display unit includes one or morelight emitters for emitting light pulses, and wherein the data isencoded in a sequence of light pulses emitted by the one or more lightemitters. This can allow to realize the tag and thus also the package ina particularly small and particularly cost-efficient way, and it maysimplify the manufacture of the tag. The data may more particularly beencoded in one or more of

-   -   the color of the light pulses;    -   a duration of the light pulses;    -   the number of the light pulses in the sequence.

The light emitters may in particular be light emitters for selectivelyemitting light of at least two different colors. For example, a lightsource for emitting green light and a light source for emitting redlight may be provided.

The light emitters may be, e.g., LEDs (light emitting diodes). LEDs havea low power consumption, which can contribute to a long operatingduration of the tag.

Usually, the tag includes merely exactly one display (and not anadditional one).

In view of the above-described (and below-described) ways of realizingthe display, it is possible to provide that the display is anot-graphical display, at least in the sense that a graphical displaywould allow to visualize a plurality of different shapes (such as shapessymbolizing letters and/or numbers).

Providing a display of the above-described kind may allow to dispensewith graphical displays, at least in the sense that a graphical display,would allow to visualize a plurality of different shapes (such as shapessymbolizing letters and/or numbers).

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments, the display automatically displays thestatus data periodically. The displaying may take place, e.g., inintervals of at least 1 second, more particularly of at least 5 seconds,and/or of at most 2 minutes, more particularly of at most 40 seconds.This may make dealing with the package easier, but usually at theexpense of battery power.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments, the control unit is structured andconfigured for receiving data or signals from the sensor unit, the dataor signals being indicative of currently present physical orenvironmental conditions, and for obtaining the status data from thesedata or signals. In order to accomplish the latter, the status data areusually obtained in dependence of prescribed limitations for theexposure of the product to the physical or environmental conditions.Those prescribed limitations are usually stored in the tag, in theelectronics unit, in form of corresponding data. For example, thecontrol unit usually will compare the current conditions to thresholdvalues such as a value that shall never be exceeded and/or a value thatshall never be fallen short of and/or a value that may be exceeded (orfallen short of) only for less than a prescribed time duration. If analarm condition is met because of extreme values (or extreme valuesduring a too long time duration), it must be assumed that the integrityof the product is not present anymore, i.e. that the product is not insound condition anymore. This fact can be indicated by the display ofthe tag, wherein it is possible to provide that different types of alarmconditions are indicated by the display in different ways.

Accordingly, the status data are usually indicative of events (inparticular failures) that have occurred after an initial point in time,namely after the moment when the integrity monitoring has started, i.e.after the beginning of the time span. Status data usually reflect onlyevents (in particular failures) that have occurred during the time span.A failure usually is a deviation from or transgression of theabove-mentioned prescribed limitations, e.g., an exceeding of athreshold value.

In one embodiment referring to the before-mentioned embodiment, datarepresentative of the prescribed limitations are programmable. Usually,such data are stored in the electronics unit, and in case they areprogrammable, there is no limitation to one (i.e. to a single) set ofsuch data. This can make possible to use one and the same tag fordifferent products of different sensitivity to the physical orenvironmental conditions. Thus, it can be sufficient to store only tagsof a single type for many different products instead of one type of tagfor each type of product.

In one embodiment referring to the before-mentioned embodiment, the tagincludes a rip strip (e.g., of an above-described kind) including atleast two contact pads (providing electrical contacts), which areoperationally (usually electrically and more particularly galvanically)connected to the control unit, and the data representative of theprescribed limitations are programmable by means of signals (usuallydigital signals) applied to the contact pads.

In a first possibility, it can be provided that one of a plurality ofsets of such data representative of the prescribed limitations areselectable by the applied signals. Those sets of data (including atleast one value each, such as a maximally allowed temperature) are inthis case usually stored in the electronics unit. Accordingly,sufficient memory space for the plurality of data sets is required inthe electronics unit. However, programming may be accomplished ratherrapidly this way. For example, if a specific type of tag shall be usedfor monitoring one of various, e.g., twenty, different pharmaceuticalproducts, each having different prescribed limitations, a correspondingnumber of sets of, e.g., threshold temperatures (and possibly also timedurations), may be stored in the electronics unit, and when a specificproduct shall be monitored, the signals applied to the contact padsallow to select the suitable set of data, such that these are applied inthe subsequent monitoring.

In a second possibility, the data representative of the prescribedlimitations are entered into the electronics unit by applying thesignals. This provides additional flexibility and requires onlyrelatively little storage space in the electronics unit. Theprogramming, however, may be more time consuming than in case of thefirst possibility.

Referring again to the contact pads, it can be provided that these arearranged in such a location of the rip strip that they are removed fromthe tag when the rip strip is ripped for indicating that the monitoringshall start, i.e. for indicating the beginning of the time span. As hasbeen described further above, a first and a second loop may be provided,a detection of an interruption of the second loop indicating thebeginning of the time span. The contact pads may thus in particular belocated, with respect to a coordinate from the control unit along theextension of the rip strip (which usually is a coordinate along thedirection of the largest extension of the rip strip), at a locationbeyond the location of that portion of the second loop which is locatedfarthest along the coordinate. A ripping of the rip strip along adirection approximately perpendicular to the coordinate by which thesecond loop is opened (interrupted) will thus usually also result in acutting off of the contact pads from the tag. Attempts to try to programthe tag (more particularly, to program data representative of theprescribed limitations) after monitoring has started can be impeded thisway.

It is to be noted that, generally, it would also be possible, as analternative or as an addition to the described programming to tags, toprovide a contactless programming, e.g., via electromagnetic radiation.This might, with respect to the above-described provision of contactpads for programming, result in a less time-consuming programming(programming possibly taking place simultaneously with other processsteps during packaging) and in higher tag manufacturing costs andpossibly also in larger outer dimensions of the tag, more particularlyof a main part of the tag.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments, the physical or environmental conditionsinclude a temperature, in particular an ambient temperature.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments, the physical or environmental conditionsinclude a pressure, in particular an ambient pressure.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments, the physical or environmental conditionsinclude a humidity, in particular a relative humidity (water content) ofthe (ambient) air.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments, the physical or environmental conditionsinclude an acceleration.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments, the sensor unit (and/or the control unit)is structured and configured for measuring the physical or environmentalconditions at various times during the time span, in particular inregular intervals.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments, the tag includes a main part including ahousing, wherein the housing can in particular be a housing as describedfurther above or below. The housing may be made, e.g., of a polymer, andit may contain the electronics unit. In particular, the housing has anopening through which a rip strip of the tag, if present, extends.

In one embodiment, which may be combined with one or more of thebefore-mentioned embodiments in which the tag includes a housing, thehousing is substantially made of an at least partially transparentmaterial, e.g., a semi-transparent or dull or opaque material.

The packaged pharmaceutical product includes a package according to theinvention and the pharmaceutical product, wherein the pharmaceuticalproduct is contained in the syringe.

In the (usual) case that the syringe includes a barrel, thepharmaceutical product is usually contained in the barrel.

The tag device includes:

-   -   a plunger top for use in or with a syringe for applying a        pharmaceutical product; and    -   an electronic tag for obtaining information relating to the        integrity of a product as assessed from an exposure of the        product to physical or environmental conditions during a time        span;        wherein        I) the tag is attached at or to the plunger top; or        II) at least a portion of the tag is integrated in the plunger        top.

The tag may, in particular, include an electronics unit including:

-   -   a control unit;    -   a sensor unit including at least one sensor for monitoring the        physical or environmental conditions;

More specifically, the electronics unit may include:

-   -   a display unit including a display for displaying data relating        to the integrity referred to as status data;    -   a switch;        wherein the control unit is structured and configured for        effecting that the display unit displays the status data in        reaction to an operation of the switch.

The pharmaceutical product, the integrity of which is monitored by thetag, is the pharmaceutical product to be contained in the syringe.

The tag may be a tag having properties of tags described elsewhereherein. In particular, the tag may include a housing, and the plungertop may be contained, at least in part, in the housing.

The tag device may also include a plunger rod integrally formed with orfixed to the plunger top. In this case, and when the tag includes ahousing, the housing may, in configuration I), have an opening throughwhich the plunger rod extends, and the opening may be the openingdescribed further above or below in the present patent application. Inthe configuration II), the tag device may include a plunger rodintegrally formed with the plunger top.

The tag device according to the invention may be a portion of thepackage according to the invention. Accordingly, it may be referred tothe description of the package for further details and properties of theconstituents of the tag device. For example, the tag may have a ripstrip; a housing of the tag may provide a holder or fixture for abattery of the tag; and so on.

The plunger device includes a plunger top for use in or with a syringefor applying a pharmaceutical product, wherein the plunger topestablishes a housing. In other words, the plunger top at leastpartially encloses a hollow. In particular, the housing is suitable foruptake of a part insertable into the housing and into the hollow,respectively. That hollow and thus the housing can, in particular, besuitable for receiving at least a portion of an electronic tag forobtaining information relating to the integrity of a product as assessedfrom an exposure of the product to physical or environmental conditionsduring a time span; in particular, the housing is suitable for receivingat least a portion of an electronics unit of the electronic tag, moreparticularly wherein the portion of an electronics unit includes abattery. The plunger device may furthermore include a plunger rod fixedat or integrally formed with the plunger top; plunger top and plungerrod may be one single molded part, e.g., injection molded part. Thehousing and the tag may each have properties as described for housingand tags, respectively, described elsewhere herein. In particular, thehousing may include a first and a second housing portion interconnectedby a folding portion of the housing, wherein the first and a secondhousing portions are foldable so as to provide a hollow inside of whichspace is provided which is suitable for uptake of the portion of theelectronic tag.

The method for monitoring an integrity of a pharmaceutical productincludes the steps of:

a) providing a syringe;

b) providing

-   -   I) an electronic tag attached at or to a constituent of the        syringe; or    -   II) an electronic tag at least a portion of which is integrated        in a constituent of the syringe;        the syringe including a barrel, the barrel containing the        pharmaceutical product;        the tag being a tag for obtaining information relating to the        integrity of the product as assessed from an exposure of the        product to physical or environmental conditions during a time        span, the tag including an electronics unit including:    -   a control unit;    -   a sensor unit including at least one sensor for monitoring the        physical or environmental conditions;    -   a display unit including a display for displaying data relating        to the integrity referred to as status data;    -   a switch;        wherein the control unit is structured and configured for        effecting that the display unit displays the status data in        reaction to an operation of the switch.

The tag and the syringe may have properties as described elsewhereherein for tags and syringes, respectively.

The method may furthermore include the step of

c) starting the time span.

Step c) may be accomplished, e.g., by breaking a breakable electricalconnection of the tag such as the one described for the rip strip thetag may comprise. In this case, step c) may be caused by ripping the ripstrip of the tag.

The method may furthermore include programming prescribed limitations ashas been described above, e.g., by applying signals to the control unit,e.g., via at least two contact pads which may in particular be providedby a rip strip of the tag.

Provided the tag includes a rip strip, the method may also include thestep of ripping the rip strip. The ripping of the rip strip may beaccomplished for terminating the integrity monitoring (and ending thetime span).

The method may furthermore include the step of operating the switch. Thestep of operating the switch may be accomplished for requesting adisplaying of the status data.

The method may furthermore include the step of:

-   -   by means of the sensor, creating data or signals representative        of the physical or environmental conditions at various times        during the time span.

The method may furthermore include the step of inserting thepharmaceutical product into the syringe, more particularly into a barrelof the syringe.

Provided that the syringe includes a plunger assembly including aplunger top, the method may include the step of:

d) attaching (or fixing) the tag to or at the plunger top.

This can, in particular, be the case in configuration I).

Step d) may be accomplished by closing a housing of the tag. The housingmay have properties of a housing as described elsewhere herein. Forexample, step d) may be accomplished by folding two portions of thehousing, such as by closing a snap fit between two housing halves.

Alternatively, step d) may include interconnecting the tag and theplunger top by and via a double-sided adhesive tape or by some otherbonding agent.

The method for manufacturing a package for a pharmaceutical productincludes the steps of:

-   A) providing at least one constituent of a syringe for applying the    pharmaceutical product;-   B) providing an electronic tag for obtaining information relating to    the integrity of the product as assessed from an exposure of the    product to physical or environmental conditions during a time span;    the method further including the step of:    CI) attaching the tag to the at least one constituent of the    syringe;    or the step of    CII) integrating at least a portion of the tag in a constituent of    the syringe.

The tag may be a tag having properties as described for a tag describedelsewhere herein. And the same applies to the syringe and to theconstituent of the syringe.

The method may in particular include the step of manufacturing a unitaryor an integrally formed part, which establishes a housing for at least apart of the tag and a constituent of the syringe. More particularly, theunitary or integrally formed part may establish a housing for at least apart of the tag, e.g., for at least a portion of an electronics unit ofthe tag, and also a constituent of a plunger assembly of the syringe.The housing may be openable, e.g., including a first and a secondhousing portion as described above, and the method may include the stepof inserting the part of the tag into the housing. Furthermore, the stepof closing the housing may be carried out.

This way, an integrated tag (integrated in a syringe) may be realized byproducing the unitary or an integrally formed part and inserting the tag(or a portion thereof) in the housing established by that part andclosing the unitary or an integrally formed part. Compared tomanufacturing a conventional package or syringe, mainly those two stepsof inserting and closing add up, besides the costs for producing the tag(or rather for an electronics unit of the tag). A mold for molding theunitary or integrally formed part will usually be more complicated thanin case of a mold merely for a conventional syringe. A singleinjection-molded part may constitute as the unitary or integrally formedpart, e.g., the tag housing, the plunger top and possibly also theplunger rod (or a portion thereof).

Provided the syringe includes a plunger assembly including a plungertop, the method may include the step of:

-   E) inserting at least a portion of the tag, e.g., the electronics    unit, into a housing established by the plunger top.

The method for manufacturing a plunger device for use in or with asyringe for applying a pharmaceutical product includes the step of:

-   K) providing a plunger top, which establishes a housing.

More specifically, the plunger top may at least partially enclose ahollow, more particularly a hollow for uptake of a part insertable intothe hollow.

In particular, the housing is suitable for receiving at least a portionof an electronic tag for obtaining information relating to the integrityof a product as assessed from an exposure of the product to physical orenvironmental conditions during a time span.

Furthermore, the plunger top may be an integrally formed part such as amolded part, e.g., an injection molded part.

The method may, accordingly, include the step of:

-   L) manufacturing the plunger top using a molding technique.

The housing may have properties as described for a housing describedelsewhere herein.

Furthermore, the plunger top may be integrally formed with a plunger rodor a portion of a plunger rod.

The method may, accordingly, include the step of:

-   M) manufacturing the plunger top integrally formed with at least a    portion of a plunger rod.

Step M) may be accomplished using a molding technique.

The method for manufacturing a tag device for use in or with a syringefor applying a pharmaceutical product includes, in a firstconfiguration, the steps of:

-   QI) providing a plunger top;-   RI) attaching an electronic tag to the plunger top; or-   or, in a second configuration, the steps of-   QII) providing a plunger top, which establishes a housing;-   RII) inserting into the housing at least a portion of an electronic    tag.

In particular, the tag can be an electronic tag for obtaininginformation relating to the integrity of the pharmaceutical product asassessed from an exposure of the product to physical or environmentalconditions during a time span.

The housing, the tag, the syringe and the plunger top may haveproperties as described for the respective items elsewhere in thepresent patent application. For example, step RI) may be accomplishedusing a double-sided adhesive tape. And the housing may be foldable. Andthe housing may have two housing portions establishing a snap fit. Andthe housing may establish a holder for a battery (of the tag).

The method may furthermore include the step of:

-   S) closing the housing (with at least the portion of the tag inside    the housing).

The method may also include the step of:

-   T) clamping a battery of the tag inside the housing.

In the method, it may be provided that the plunger top is fixed to orintegrally formed with at least a portion of a plunger rod.

The method may, in the second configuration also include the step of:

-   L) manufacturing the plunger top using a molding technique.

And, in the second configuration, the method may include the step of:

-   M) manufacturing the plunger top integrally formed with at least a    portion of a plunger rod.

As mentioned above, step M) may be accomplished using a moldingtechnique.

In a particular view of the invention, some properties of the tag areoptional (but may, however, be nevertheless be provided), and at least aportion of the tag is integrated in a constituent of the syringe. Inthis case, the package for a pharmaceutical product includes:

-   -   a syringe;    -   an electronic tag for obtaining information relating to the        integrity of the product as assessed from an exposure of the        product to physical or environmental conditions during a time        span;        wherein at least a portion of the tag is integrated in a        constituent of the syringe.

The tag may, more particularly, include an electronics unit including:

-   -   a control unit;    -   a sensor unit including at least one sensor for monitoring the        physical or environmental conditions.

And it may, as another option, also include:

a display unit including a display for displaying data relating to theintegrity referred to as status data; and

a switch;

wherein the control unit is structured and configured for effecting thatthe display unit displays the status data in reaction to an operation ofthe switch.

Generally, further options and embodiments concerning this particularview of the invention can be derived from the description above andbelow. This concerns also the methods (monitoring methods, manufacturingmethods) and the packaged pharmaceutical product and other devices. Inparticular, the integration of at least a part of the tag in aconstituent of the syringe may mean that a housing of the tagestablishes a constituent of the plunger assembly of the syringe and inparticular of a plunger top of the syringe.

It is readily understood that features mentioned with respect to acertain portion of the invention, e.g., for a manufacturing method orfor a device, can be provided—as far as logically meaningful and atleast in analogy—in other portions of the invention, e.g., in a packageor in a monitoring method. The achievable effects correspond to eachother.

The advantages of the methods basically correspond to the advantages ofcorresponding apparatuses and vice versa.

Further embodiments and advantages emerge from the dependent claims andthe figures.

BRIEF DESCRIPTION OF THE DRAWINGS

Below, the invention is described in more detail by means of examplesand the included drawings. The figures show schematically:

FIG. 1 a top view onto an electronic tag;

FIG. 2 a cross-sectional view of an attached electronic tag;

FIG. 3 a cross-sectional view of an attached electronic tag;

FIG. 4 a symbolic cross-sectional view of a package;

FIG. 5 an illustration of sequences of light pulses emittable by anelectronic tag;

FIG. 6 a top view onto an electronic tag;

FIG. 7 an illustration of method steps;

FIG. 8 an illustration of method steps;

FIG. 9 a strongly schematized illustration of a tag attached at aplunger top by containing the plunger top;

FIG. 10 a strongly schematized illustration of a plunger top withintegrated tag;

FIG. 11 a strongly schematized illustration of an assembly stepinserting a plunger rod into a housing portion of a tag;

FIG. 12 a strongly schematized illustration of a constituent of aplunger assembly including plunger top and plunger rod and integrating afoldable housing for an electronic tag;

FIG. 13 a strongly schematized illustration of a plunger top integratinga foldable housing for an electronic tag;

FIG. 14 a strongly schematized illustration of a plunger top integratinga foldable housing for an electronic tag;

FIG. 15 a perspective view onto an assembly including a plungertop/plunger rod part and a housing of an electronic tag;

FIG. 16 a different perspective view onto the assembly of FIG. 15;

FIG. 17 a perspective view onto an assembly including a plungertop/plunger rod part and an electronic tag;

FIG. 18 a perspective view onto an assembly of a plunger top/plunger rodpart and an electronic tag;

FIG. 19 a perspective view onto the assembly of FIG. 18, but with openhousing.

FIG. 20 a perspective view onto a portion of the assembly of FIGS. 18and 19.

DETAILED DESCRIPTION OF THE INVENTION

The described embodiments are meant as examples and shall not limit theinvention.

FIG. 1 shows a schematized top view onto an electronic tag 1. Tag 1includes a temperature sensor or a sensor for some other physical orenvironmental condition. The tag can monitor that magnitude and decidewhether or not certain (prescribed) conditions concerning that magnitudeare met, e.g., whether or not a threshold value has been exceeded andpossibly also for how long it has been exceeded. Depending on themonitored (sensed or measured) values (of temperature, pressure,humidity, acceleration or others and usually also of the time), one ormore types of alarm indications can be provided by the tag, depending onthe type of event or failure that occurred. Since such functionalitiesare known from prior art, we will not go into much detail hereconcerning this point.

Tag 1 of FIG. 1 includes a main part 2 and a rip strip 3, which aremutually interconnected. The main part 2 typically has a volume of atmost 35 mm×30 mm×12 mm, in particular having a side length of, at most,the specified lengths, and more particularly, it may have a volume of atmost 25 mm×20 mm×10 mm, and in particular a side length of, at most, thespecified lengths.

The main part 2 includes an electronics unit including i.a. auser-operable switch 9 (cf. the dotted hand symbol in FIG. 1) and adisplay 6 substantially consisting of two light emitters 7, 8 such astwo LEDs, in particular a red LED and a green LED. The rip strip 3substantially consists of a printed circuit board (PCB) or of a piece orpart thereof and more particularly of PCB base material 4 in and/or onwhich conductor lines 5 are present. It is particularly suitable toprovide, as the rip strip 3, an electrically insulating foil 4 such as apolymer foil provided with conductor lines 5.

In fact, the electronics unit (having reference symbol 40 in furtherfigures) and the rip strip 3 may be considered to share one printedcircuit board. And the electronics unit 40 may be considered to be aprinted circuit board assembly (PCB assembly or PCBA), i.e. a PCB withcomponents mounted thereon (the components being described above andalso below), wherein the PCB forming the rip strip 3 is continuous withthe PCB of the PCBA representing the electronics unit 40.

FIG. 2 shows a schematic cross-sectional view of an attached electronictag 1, and at the same time, FIG. 2 may be interpreted to show aschematized detail of a package 10 including a syringe (the syringebearing reference numeral 70 in further figures). The tag 1 of FIG. 2may be identical with the one of FIG. 1.

Tag 1 includes electronics unit 40 in its main part 2 and rip strip 3,each including a portion of one and the same PCB, which may be aflexible PCB.

Tag 1 and, more particularly, main part 2 includes a housing 41 in whichelectronics unit 40 is present. Electronics unit 40 includes, besidesthe PCB and mounted thereon, an energy source such as a battery 42, theabove-mentioned switch 9, which may be, e.g., an electro-mechanicalswitch or a capacitive switch, the light emitters of the display (onlyLED 7 being illustrated in FIG. 2) and an integrated circuit (IC) 44such as an ASIC (application-specific IC). IC 44 may embody a controlunit and a sensor unit, but it is also possible that a separate sensorunit is mounted on the PCB.

It is possible that data sensed by a sensor of the sensing unit arecontinuously (or quasi-continuously) taken, but usually, measuring orsensing takes place in time intervals of between 30 seconds and 12hours, more particularly between 1 minute and 30 minutes, so as to saveenergy.

Housing 41 may be made substantially of a material which is sufficientlytransparent for letting light emitted by light emitters 7, 8 of tag 1pass through such that it is visible from the outside, or may include,as indicated in FIG. 2, a transparent or (particularly) thin portion 49for that purpose.

In order to attach tag 1 to a tag carrier 11 such as a constituent of asyringe, e.g., a plunger top, a double-faced adhesive tape 15 may beused. An alternative would be to use a different bonding technique suchas the application of an initially liquid bonding material such as aglue. A bonding may take place between the housing 41 and the tagcarrier 11, and it is possible, as indicated in FIG. 2, to provide thatit takes place, in addition, between the battery 42 and the tag carrier11. In the latter case, the adhesive tape 15 or other bonding materialmay function as a part of the housing of the tag 1.

An alternative way of attaching tag 1 to a tag carrier 11 is illustratedin FIG. 3. In the embodiment of FIG. 3, the tag may be identical withthe one of FIG. 1, and its electronics unit 40 may be identical with theone of FIG. 2. However, the attaching of main part 2 to tag carrier 11is accomplished in an indirect way. More specifically: A foil 18 such asa polymer foil holds main part 2 between itself and tag carrier 11. Inan area partially surrounding main part 2, foil 18 is bonded to tagcarrier 11 using a bonding material such as a glue (indicated at 19 inFIG. 3, but not separately drawn). Thus, main part 2 is sandwichedbetween foil 18 and tag carrier 11.

Suitable tag carriers 11 are constituents of a syringe to be providedwith a tag, e.g., the barrel of the syringe or a constituent of theplunger arrangement of the syringe. Below, a plunger top will bedescribed as a possible tag carrier, but also a barrel of a syringe willbe described as a possible tag carrier.

A pharmaceutical product (later referenced by reference numeral 24) tobe monitored by means of the tag is contained in the syringe, moreparticularly in a barrel of the syringe. The pharmaceutical productusually will be provided in liquid form, so as to be injectable usingthe syringe.

FIG. 4 is a symbolic cross-sectional view of a two-level package 10 andof a corresponding packaged pharmaceutical product 24. Pharmaceuticalproduct 24 is contained in a barrel 72 of syringe 70. Syringe 70includes barrel 72 and needle hub 74 (also referred to as adaptor) andplunger assembly 75. Plunger assembly 75 includes plunger seal 79 andplunger rod 78 and plunger top 77.

Syringe 70 is contained in a blister-type package 22 usually made of apolymer (and possible also paper-type material) which again is containedin a box 12, which typically is a folding carton. Instead of such atwo-level package 10, also a single-level package might be used forpackaging product 24, e.g., providing box 12 only (and no blister-typebag) and providing a blister-type package 22 only (and no additionalbox).

Whatever constitutes the outer-most package level (in FIG. 4 it is box12) intended for the end-user (typically patient or health careprofessional), it may be provided that therein, no further syringe butone single syringe is present. For example, in a folding carton, onesyringe (and not more than one) may be present, however, it is possiblethat, in addition, one or two or more containers each containing anotherpharmaceutical product are present inside the folding carton, e.g., oneor more vials. This may, in particular, be useful in case that thepharmaceutical products are vaccines (such as different vaccines for asingle person/patient).

It is to be noted that it is possible that inside a package, e.g.,inside a folding carton or a blister-type package, two or more parts (orconstituents) of the syringe are separate, i.e. disassembled. Inparticular, the plunger top (including the tag) and the plunger rod (ora portion of the plunger rod) may be one part which is separate fromanother part which establishes the barrel and the plunger seal (andpossibly also a portion of the plunger rod). Before use, the syringethen has to be assembled from the separate parts.

Providing a disassembled syringe can allow to package the syringe(including the tag) in a smaller outer package, e.g., a smaller foldingcarton. And an accidental pressing of the pharmaceutical product out ofthe barrel may be largely inhibited.

A tag 1, e.g., a tag like described elsewhere in the present patentapplication, e.g., in FIG. 1 or 2, is attached to syringe 70 and moreparticularly to plunger top 77. As indicated by dotted lines, it is alsopossible to provide another tag 1′ (which includes a main part 2′ and arip strip 3′) at a different constituent of syringe 70, e.g., asillustrated, at barrel 72. In particular, it may be provided that in onefolding box (such as folding box 12 in FIG. 4), exactly one syringe ispresent (and no further syringe).

Bag 22 is a container which usually is at least partially constituted bya polymer foil, in particular by transparent polymer foil.

A tag 1, e.g., one as described above, and, more particularly, thecorresponding electronics unit 40 can be structured and configured fordetecting an interruption of a conductor line loop of rip strip 3, e.g.,by cutting rip strip 3 using a cutting tool or by ripping rip strip 3 byhand. And, moreover, this may result in a termination of the monitoring(and of the measurements and of the sensing) being accomplished (or atleast evaluated) by the tag 1.

Accordingly, it can be provided that monitoring the integrity of aproduct 24 is carried out from a starting event to an end point. Thestarting event can be, e.g., when syringe 70 is packaged in an outerpackage (in particular into a folding box), or when syringe 70 isassembled (with product 24 in barrel 72), or when product 24 is filledinto barrel 72. The end point may be indicated by a ripping of rip strip3. And this ripping can be linked to an accessing of product 24, e.g.,by prescribing (to a user such as a patient or a health care specialist)that rip strip 3 has to be ripped when box 12 is opened or when thesyringe is about to be used (for giving a shot). This way, it can beensured to some extent that the monitoring of the integrity of product24 is terminated when product 24 is accessed. The integrity status ofproduct 24 may, also in reaction to the ripping, be stored in tag 1 suchthat it can be recalled later (namely by operating switch 9, cf. FIGS.1-3) and/or may be displayed by the display 6 of tag 1, e.g., by theemission of light pulses.

A beginning of the time span during which the physical or environmentalconditions are monitored may be indicted by breaking another looppresent on rip strip 3, cf. also FIG. 7 below. For example, dividing therip strip of FIG. 1 along the dashed line s2 (and thus opening thelonger one of the two loops present on rip strip 3) may be detected byelectronics unit 40 (and more particularly by a control unit realizedtherein) by an increase of an ohmic resistance and make the electronicsunit 40 start the monitoring. On the other hand, dividing the rip stripof FIG. 1 along the dashed line s1 (and thus opening the shorter one ofthe two loops present on rip strip 3; the longer one being already open)may be detected by electronics unit 40 (and more particularly by acontrol unit realized therein) by an increase of an ohmic resistance andmake the electronics unit 40 terminate (stop) the monitoring.

Alternatively, the monitoring can be started differently, cf. below atthe description of FIG. 8 (“initiating switch”). In that case, a singleconductor line loop may be sufficient, and rip strip 3 may remainunripped at least until after packaging, i.e. at least up toforwarding/shipping the packaged pharmaceutical product 24. Furthermore,rip strip 3 (cf. FIG. 6) might in general be dispensed with. In thatcase, the tag is substantially identical with its main part.

As is clear from the above, a display 6 of a tag 1 may include (an inparticular essentially consist of) one or more light emitters such asLEDs, in particular light emitters of different color, e.g., oneemitting red light and another emitting green light. A control unit oftag 1, e.g., an integrated circuit, e.g., the one of FIGS. 2, 3, maycontrol the display 6 to emit light pulses, more particularly sequencesof light pulses (wherein already a single light pulse shall beconsidered a sequence of light pulses). Emitted light pulses in asequence may differ in at least one of color, duration, intensity.Assuming that color is a parameter which can be varied for displayingintegrity status information, generally, the emission of green light maybe emitted in order to indicate that the product integrity is still inorder, and the emission of red light may be emitted in order to indicatethat the product integrity is not in order anymore.

Assuming that in addition, the duration (of a pulse in a sequence) is aparameters which can be varied for displaying integrity statusinformation, it can be provided, e.g., that two or more types of alarm(or types of failures) are indicated by different pulse durations. Anexample will be illustrated and described by means of FIG. 5.

FIG. 5 is an illustration of sequences of light pulses emittable by anelectronic tag 1 such as by an above-described tag 1. The curves “a” to“e” illustrate different sequence which may be emitted in 5 differentcases, i.e. in five different integrity statuses. The horizontal axis isthe time axis, the vertical axis is the light intensity axis,intensities being either zero or a maximum value.

One way of distinguishing three types of failures (one, two or three ofwhich may have occurred and thus may have to be indicated whendisplaying the integrity status) works as follows:

If a failure of a first type has occurred, a single short red pulse isemitted (cf. curve a).

If a failure of a second type has occurred, a two short red pulses areemitted (cf. curve b).

If failures of both, first and second type, have occurred, a three shortred pulses are emitted (cf. curve c).

If a failure of a third type has occurred, a single long red pulse isemitted (cf. curve d).

If, in addition to a failure of the third type, a failure of the firstand/or a failure of the second type has occurred, the (partial) sequencefor the additional failure(s) is appended to the long red light pulseindicating the third type failure. Curve e indicates the case that afailure of a first type and a failure of a third type have occurred.

A failure of first type may mean, e.g., that an upper temperature limitT(up) has been exceeded.

A failure of second type may mean, e.g., that a lower temperature limitT(low) has been fallen short of

A failure of third type may mean, e.g., that a threshold temperaturelimit T(thr) has been exceeded (or fallen short of) for a too long time,more particularly for more than a prescribed threshold time t(thr).

Such a kind of data indicative of prescribed limitations of a product,e.g., T(up), T(low), T(thr) and t(thr), are usually stored in theelectronics unit. They may be programmable in a way described furtherabove in the present patent application. If programming pads areprovided for programming such values, these may in particular beprovided on the rip strip. FIG. 6 illustrates a possible design of a ripstrip with contact pads for programming such values.

FIG. 6 shows an illustration of a top view onto an electronic tag 1.This tag 1 can be largely identical with other tags described in thepresent patent application, such as tag 1 of FIG. 1, but the rip strip 3is designed to provide two contact pads 60, 66. While conductor lines 5form two loops L1, L2 which may (as illustrated) partially overlap andare readily interrupted by ripping rip strip 3 along separation liness1, s2, conductor line 50 provides an electrical connection between pad60 and the electronics unit of tag 1, and conductor line 55 provides anelectrical connection between pad 66 and the electronics unit of tag 1.Via contact pads 60, 66, data indicative of prescribed limitations of aproduct to be monitored (such as the above-mentioned T(up), T(low),T(thr) and t(thr)) may be programmed before ripping rip strip 3 along s1or s2.

In the process of packaging pharmaceutical products, a (high) number ofsuch tags 1 may be present, and an arbitrary one of them is selected forthe next product, and then—when the type of product to be packaged isknown—the data indicative of prescribed limitations of that specificproduct for the exposure of that specific product to the monitoredphysical or environmental conditions are programmed (using pads 60 and66). This way, in a single packaging line, the provision of a singletype of tag 1 can be sufficient for packaging (and monitoring) in thatpackaging line a plurality of different products (with differentprescribed limitations). Accordingly, storing various different types oftags, each specifically designed for the different products to bepackaged (set to the respective specific prescribed limitations for theexposure of the product to the physical or environmental conditions),may become superfluous this way.

And starting the monitoring by opening loop L2, e.g., by cutting alongline s2, will simultaneously make a reprogramming of tag 1 difficult,thus impeding tampering with the tag.

If product integrity is in order, this may be indicated by one or moregreen light pulses. It is, more specifically, possible to distinguishdifferent types of (still-)in-order statuses. For example, in a firstcase, a single green pulse is emitted, cf., e.g., curve a or curve e.And in a second case, two green pulses are emitted, cf., e.g., curve b,or more than two pulses are emitted, or green and red pulses areemitted.

The first (still-)in-order status case may be, e.g., that no thresholdvalue has been reached. In case a temperature is monitored, this wouldbe the case, e.g., if the temperature never left the range at which theproduct may be kept virtually forever or (as more often will be thecase) until its expiration date.

The second (still-)in-order status case may be, e.g., that for more thana pre-selected time duration, a threshold value has been exceeded andfallen short of, respectively, (depending on the threshold being anupper and a lower threshold value, respectively). For example, in case atemperature is monitored, this would be the case, e.g., if thetemperature of the product may be above an upper threshold of, e.g., 37°C. for at most, e.g., 72 hours, and an alarm is desired as soon as only24 hours or less are left (24 hours being the pre-selected timeduration). If then the temperature has in fact been above 37° C. foralready more than 48 hours, such that the product will be in order foronly less than 24 hours (provided that its temperature will remain above37° C.), the second (still-)in-order status shall be indicated.

FIG. 7 illustrates method steps. Reference symbol t denotes the time, dtdenotes the time span during which monitoring takes place. In steps 100,110, the time span during which integrity monitoring shall take place isstarted by interrupting a first electrical contact, e.g., by opening aconductor line loop, cf. also dashed line s2 in FIG. 1. Operating switch9 during the subsequent time span (step 120) results in a displaying ofthe status data (step 130).

Interrupting another electrical contact (cf. step 140) results interminating the time span and the monitoring (step 150), obtaining thefinal status data (step 160) and displaying the final status data (step170). When later on, switch 9 is operated (step 180), the final statusdata are displayed (step 190).

It is to be noted that usually, the status data will not be permanentlydisplayed, but only when the switch 9 is operated; and optionally alsowhen the time span (and thus the monitoring) is terminated and/oroptionally in (regular) time intervals (controlled by the control unit),the time intervals being usually between 1 second and 2 minutes, moreparticularly between 10 seconds and 1 minute.

FIG. 8 is another illustration of method steps, similar to the one ofFIG. 7. It illustrates an example for the case that no switch isrequired for displaying the status data. Instead, the status data aredisplayed periodically, before and after terminating the monitoring, cf.steps 230 and 290. And FIG. 8 also illustrates an example for the casethat monitoring is started without needing a rip strip for that purpose.Instead, the monitoring is started in reaction to the operation of aswitch, referred to as initiating switch, cf. step 200. It can bereferred to FIG. 2 for illustrating a corresponding electronic tag 1,wherein the item referenced 9 in this case is interpreted as such aninitiating switch, i.e. as a switch, when operated, effecting that themonitoring starts. Such a switch may be an electro-mechanical switch, acapacitive switch, a magnetic switch or an inductive switch. Note thatit is possible to nevertheless provide in this case a rip strip—inparticular for the purpose of terminating the monitoring. Butalternatives thereto are possible, e.g., a switch (e.g., thebefore-mentioned initiating switch) may be provided for that purpose.

Otherwise, the method and the corresponding package and tag may be asdescribed elsewhere herein.

Note that the initiating switch may in particular be a magnetic orinductive switch. For example, the manufacturing of the retail packageor retail unit may include moving the same along a path along which asuitable magnet (permanent or electromagnet) and a suitable coil,respectively, is suitably positioned, e.g., along a path described by aconveyor transporting the retail package or retail unit. Then, whilepassing along the respective magnetic or electric field, the initiatingswitch is operated (without mechanically contacting the tag), and themonitoring starts. However, the initiating switch might also be anelectro-mechanical or a capacitive switch, the latter also allowing acontact-free operation.

Of course, it is also possible to provide in the embodiment of FIG. 8the before-described switch by means of which a displaying of the statusdata can be initiated (display switch). This switch (sufficientlydescribed above) may be identical with the initiating switch or be anadditional switch. In case the switches are identical, it may beprovided that different effects may be provoked by differently operatingthe switch. For example, a brief operation of the switch (e.g., for atmost 1.5 seconds) provokes a displaying of the status data, whereas alonger operation (e.g., for at least 3 seconds) can effect that themonitoring starts. Moreover, the function of the rip strip (forterminating the monitoring) may also be assumed by the switch, e.g.,termination of monitoring is in that case effected in reaction tooperating the switch for an even longer time (e.g., for at least 8seconds). In this case, the rip strip may be dispensed with.

Instead of bonding the tag 1 to a part of the syringe 70, tag 1 can beattached thereto in a different manner or even be integrated, at leastin part, therein. The following examples basically refer to the plungertop as a syringe constituent to or at which the tag is attached or inwhich a part of the tag, such as in particular a housing of the tag, isintegrated. But other constituents of the syringe may also be used forattaching or integrating the tag.

FIG. 9 illustrates in a strongly schematized manner a tag 1 attached ata plunger top 77 by containing the plunger top 77. The tag can be a tagas described elsewhere herein, e.g., in FIG. 1 or 2. The housing 41,symbolized by thick lines, has an opening through or into which plungerrod 78 extends.

PCB 34 of tag 1 is present between battery 42 and the electroniccomponents of tag 1.

In order to be able to insert electronics unit 40 into housing 41, thelatter may be dividable into two (or possibly more) parts, e.g., alongthe dotted line in FIG. 9.

Plunger rod 78 may be fixed to plunger top 77, e.g., by a threading (notillustrated in FIG. 9).

However, plunger rod 78 may alternatively be integrally formed withplunger top 77, e.g., the two being a single injection molded part. Inthis case, for assembling housing 41 and the plunger top/plunge rodpart, the lower half of housing 41 (which has the above-mentioned hole)may be pushed over the plunger rod, with the hole, from the free end ofplunger rod 78. With the two housing halves still separate, electronicsunit 40 can be inserted into housing 41, and then, housing 41 can beclosed, which in addition attaches tag 1 to plunger top 77.

FIG. 10 is a strongly schematized illustration of a plunger top 77 withintegrated tag 1. In this case, plunger top 77 constitutes a housing 41for at least a portion of tag 1, in particular for electronics unit 40.If a rip strip is comprised in a tag, the rip strip will usually not behoused by a housing 41. A part illustrated in FIG. 10 fulfills thefunctions of both, being the plunger top for or of a syringe, and beinga housing for at least a portion of an electronic tag.

The housing 41 of FIG. 10 may be dividable into two (or possibly more)parts, e.g., along the dotted line in FIG. 10.

The housing in FIG. 9 and also the housing 41 in FIG. 10 may beintegrally formed, e.g., being a single molded part.

FIG. 11 is a strongly schematized illustration of an assembly stepinserting a plunger rod 78 into a housing portion 46 of a tag 1. FIG. 11can be seen in conjunction with FIG. 9, since in both cases, a plungerrod 78 may have to be inserted into an opening of a housing part(referenced 46 in FIG. 11), so as to provide that a plunger top 77 ispresent inside a housing 41 of a tag 1, whereas a plunger rod 78 extendsout of the housing 41. With the opening being designed as sketched inFIG. 11, plunger rod 78 can be entered sideways. This can be useful inparticular if a plunger seal is present at an end of the plunger rod 78which cannot be removed, e.g., the plunger assembly already beingassembled with the barrel of the syringe.

FIGS. 12 to 14 can be seen in conjunction with FIG. 10, since theyconcern the configuration in which a part of the tag is integrated in apart of the plunger assembly, more particularly in the plunger top 77.In FIGS. 12 to 14, the housing 41 includes a first housing portion 45and a second housing portion 46 which are interconnected by a foldingportion 47. All these parts may be integrally formed. They may, e.g., bea single injection molded part.

FIG. 12 is a strongly schematized illustration of a constituent of aplunger assembly including plunger top 77 and plunger rod 78 andintegrating a foldable housing 41 for an electronic tag 1. In this case,housing 41, plunger top 77 and plunger top 78 are integrally formed.Plunger rod 78 may have, as illustrated in FIG. 12, an outer threading48 for connecting it to a plunger seal. Other ways of establishing theconnection may be provided, e.g., bonding, and a plunger seal may alsobe integrated.

FIG. 13 is a strongly schematized illustration of a plunger top 77integrating a foldable housing 41 for an electronic tag 1. In this case,plunger top 77 includes an outer threading 48 for attaching a plungerrod. Also here, other ways of establishing the desired connection may beapplied, e.g., bonding.

FIG. 14 is a strongly schematized illustration of a plunger top 77integrating a foldable housing 41 for an electronic tag 1, wherein inthis case, plunger top 77 includes an inner threading 43 for attaching aplunger rod. Also here, other ways of establishing the desiredconnection may be applied, e.g., bonding.

FIG. 15 is a perspective view onto an assembly of a plunger top77/plunger rod 78 part (which in particular may be integrally formed,cf. also the description concerning FIGS. 9 and 11) and a housing 41 ofan electronic tag 1. Plunger rod 78 is pushed through the opening in asecond portion 46 of housing 41. The second portion 46 is foldable ontoa first portion 45 of housing 41. The two housing portions areinterconnected by a folding portion 47 of housing 41, which may beresilient due to its (reduced) thickness, or the material of whichhousing 41 is made is (generally) sufficiently resilient.

First housing portion 45 provides two transparent portions which may bewindows (in particular be having a reduced thickness) or openings (notdrawn in FIG. 16). LEDs of a display unit of an electronics unit to beinserted into housing 41 are better visible this way.

In addition, housing 41 provides a flexible portion 38 which is definedby a slit in housing 41. A switch of an electronics unit to be insertedinto housing 41 can be more easily approached this way. Pushing theflexible portion 38 from outside housing 41 can allow to readily operatea switch positioned below the flexible portion 38.

The two housing portions 45, 46 can be designed to establish a snap fit.This way, housing 41 can be readily closed (after inserting theelectronics unit), and a well-defined alignment of the housing parts canbe achieved this way.

FIG. 16 is a different perspective view onto the assembly of FIG. 14. Inthis view, the inside of housing 41 can be seen. Plunger top 77 ispresent inside housing 41.

Housing 41 includes another opening, referenced 37, through which a ripstrip (if present in the tag) may extend out of housing 41.

Furthermore, housing 41 provides a holder or fixture for a constituentof the tag, in particular for a battery of the tag. For establishingthis, e.g., protrusions 39 like illustrated in FIG. 16, e.g., ribs, maybe provided.

FIG. 17 is a perspective view onto an assembly of a plunger top77/plunger rod 78 part and an electronic tag 1. FIG. 17 may beunderstood as the assembly of FIGS. 15 and 16, but including the tag 1.Housing 41 is closed, portions 45 and 46 are snapped into each other,and the electronics unit 40 is inserted. A rip strip 3 of tag is extendsout of housing 41.

FIG. 18 is a perspective view onto an assembly of a plunger top77/plunger rod 78 part and an electronic tag 1. A first way ofinterpreting FIG. 18 is to understand it as another view of the assemblyof FIG. 17.

However, the assembly of FIG. 18 can also be understood, in a secondinterpretation, as illustrating an example for an integrated tag. Inthis case, housing 41 establishes plunger top 77 or, vice versa, plungertop 77 establishes housing 41 of the tag 1. Thus, a single integrallyformed part may include housing 41 (including all its parts) and plungertop 77 and, optionally also plunger rod 78. FIGS. 12 to 14 schematicallyvarious possible variations.

FIG. 19 is a perspective view onto an assembly of FIG. 18, but withhousing 41 open. It may be interpreted in the same two ways as FIG. 18can be interpreted.

Electronics unit 40 and its constituents are well visible in FIG. 19.Battery 42 is connected to PCB 34 via two contacts 35. Battery contactleads may be bonded to battery 42 which lead to the contacts 35.

At flexible portion 38, a protrusion 38 a may be provided whichfacilitates operating switch 9 (with housing 41 closed).

FIG. 20 is a perspective view onto a portion of the assembly of FIGS. 18and 19. In FIG. 20, housing portion 46 is not drawn, but housing portion45 is. The electronics unit 40 is inserted in housing portion 45. Since,in the embodiments of FIGS. 16, 19 and 20, battery clamping takes placein housing portion 45, insertion of electronics unit 40 is accomplishedrather in the way suggested by in FIG. 20 than in FIGS. 16 and 19.

A battery contact lead 33 contacting battery 42 is visible in FIG. 20.

Described arrangements of the tag and the switch at the plunger topallow to make sure that a person about to use (operate) the syringewill, practically inevitably, effect a display of the integrity status.Pressing against the plunger top or a portion of the tag present therefor pressing some of the pharmaceutical product or air present in thesyringe out of the syringe can result in operating the switch (“displayswitch”), such that the integrity status is displayed. In case thedisplay indicates that the pharmaceutical product has been exposed todetrimental conditions, an injection of (probably) perished medicationcan be avoided.

The tag, the package and the packaged pharmaceutical product describedin the present patent application are easy to use and operable byuntrained personnel, i.e. by people not specifically instructed on howto use the tag, the package, the packaged pharmaceutical product, as faras the integrity monitoring is concerned. Patients and health carespecialists who apply or use the pharmaceutical product can, withoutadditional measures and without the need of additional tools, check theintegrity of the product to be applied or used. And this can beaccomplished (at least approximately) at the time when the product isapplied or used. Suitably positioning the tag and in particular the(display) switch can make a display of status data (practically)unavoidable at the time the syringe (and the pharmaceutical product) isabout to be used, cf. above.

It can happen that pharmaceutical products are returned from theacquirer or user (e.g., patient or health care specialist) to themanufacturer or the distributor without having been used. This sometimesis the case, e.g., in case of particularly valuable products.

If the product is returned to the manufacturer or distributor, themanufacturer or distributor can check the integrity status of theproduct by using the tag. Based thereon, it can, e.g., be decidedwhether or not to forward the product to another acquirer or user.

Independently of having checked the integrity status or not, it may beprovided that the manufacturer or distributor forwards the product toanother acquirer or user. That other acquirer or user can then (e.g.,when the product is about to be applied) check the integrity status ofthe product using the herein described tag and the package,respectively.

It shall be noted that the tag, the package and the packagedpharmaceutical product provide standalone solutions which do not requirefurther equipment, at least not for having the integrity status of theproduct displayed. And the attaching of the tag to the syringe can beaccomplished by the manufacturer or by the packaging company packagingthe product in a box.

The tag may consist of merely:

-   -   an electronics unit; and    -   a PCB (typically a flexible PCB) forming, if present, the rip        strip, and the PCB on which the components of the electronics        unit are mounted;        wherein the electronics unit may consist merely of:    -   a switch (and possibly also a second switch—namely, e.g., for        starting the monitoring);    -   one or more, typically two, light emitters, typically LEDs;    -   an integrated circuit (embodying at least the control unit); and    -   an energy source such as a battery;        wherein, if the one or more sensors are not integrated in the        integrated circuit, at least one sensor is, in addition,        comprised, too, in the electronics unit, and        wherein optionally up to four capacitors and/or up to four        resistors may be comprised, too, in the electronics unit. And        typically, all components comprised in the electronics unit are        mounted on the PCB, more precisely on one and the same PCB.

Note that the PCB can be sufficient for electrically contacting theenergy source (battery), cf. FIGS. 2, 3, such that no separate batteryholder or battery holder leads needs to be provided. However, thebattery may be contacted by one or more (typically two) contactleads—which again are operationally (and usually galvanically) connectedto the PCB, cf. FIGS. 19, 20.

And note furthermore, that it is possible that the rip strip isdispensed with (at least in its function as providing a means forstarting the monitoring) and/or the switch may be dispensed with (atleast in its function as a means for requesting a displaying of thestatus data, and this at least for times not coinciding with the time ofterminating the monitoring).

A display of an above-described kind can be particularly small andcost-efficient. There is no need for a liquid crystal display or thelike.

The invention claimed is:
 1. A package for a pharmaceutical product,said package comprising a syringe; an electronic tag for obtaininginformation relating to the integrity of the product as assessed from anexposure of said product to physical or environmental conditions duringa time span; wherein I) said tag is attached at or to a constituent ofsaid syringe; or II) at least a portion of said tag is integrated in aconstituent of said syringe; and wherein said tag comprises anelectronics unit comprising a control unit; a sensor unit comprising atleast one sensor for monitoring said physical or environmentalconditions; a display unit comprising a display for displaying datarelating to said integrity referred to as status data; a switch; whereinsaid control unit is structured and configured for effecting that saiddisplay unit displays said status data in reaction to an operation ofsaid switch.
 2. The package according to claim 1, wherein saidconstituent of said syringe is a plunger top.
 3. The package accordingto claim 1, wherein a housing of said tag is integrated in saidconstituent of said syringe.
 4. The package according to claim 1,wherein the tag is attached to or at said constituent of the syringe,and wherein at least a portion of said constituent of the syringe iscontained in the tag or in a constituent of the tag, more specificallyin a housing of the tag.
 5. The package according to claim 3, whereinand said housing and said constituent of said syringe are integrallyformed.
 6. The package according to claim 4, wherein said constituent ofsaid syringe is a plunger top, the syringe comprising a plunger rod,wherein a constituent of the tag has an opening, said plunger rodextending into or through said opening.
 7. The package according toclaim 1, wherein the package comprises a pressing surface for operatingsaid syringe by pressing against said pressing surface, and wherein saidpressing surface is provided by said tag, and wherein said switch isstructured and arranged in such a way that it is operated when pressureis exerted against said pressing surface for operating the syringe. 8.The package according to claim 1, wherein the tag comprises a housingcomprising a first and a second housing portion which are mutuallyattachable by establishing a snap fit with one another.
 9. The packageaccording to claim 1, wherein the tag comprises a rip strip comprising abreakable electrical connection operationally connected to said controlunit.
 10. The package according to claim 1, wherein said display unitcomprises one or more light emitters for emitting light pulses, andwherein said status data is encoded in a sequence of light pulsesemitted by said one or more light emitters.
 11. A packagedpharmaceutical product, comprising a package according to claim 1 andsaid pharmaceutical product, wherein said pharmaceutical product iscontained in said syringe.
 12. A device, comprising a plunger top foruse in or with a syringe for applying a pharmaceutical product; and anelectronic tag for obtaining information relating to the integrity of aproduct as assessed from an exposure of said product to physical orenvironmental conditions during a time span; wherein I) said tag isattached at or to said plunger top; or II) at least a portion of saidtag is integrated in said plunger top; and wherein said tag comprises anelectronics unit comprising a control unit; a sensor unit comprising atleast one sensor for monitoring said physical or environmentalconditions; a display unit comprising a display for displaying datarelating to said integrity referred to as status data; a switch; whereinsaid control unit is structured and configured for effecting that saiddisplay unit displays said status data in reaction to an operation ofsaid switch.
 13. A device, comprising a plunger top for use in or with asyringe for applying a pharmaceutical product, wherein said plunger topestablishes a housing suitable for receiving at least a portion of anelectronic tag for obtaining information relating to the integrity of aproduct as assessed from an exposure of said product to physical orenvironmental conditions during a time span; and wherein said tagcomprises an electronics unit comprising a control unit; a sensor unitcomprising at least one sensor for monitoring said physical orenvironmental conditions; a display unit comprising a display fordisplaying data relating to said integrity referred to as status data; aswitch; wherein said control unit is structured and configured foreffecting that said display unit displays said status data in reactionto an operation of said switch.
 14. A method for manufacturing a packagefor a pharmaceutical product, the method comprising the steps of A)providing at least one constituent of a syringe for applying saidpharmaceutical product; B) providing an electronic tag for obtaininginformation relating to the integrity of said product as assessed froman exposure of said product to physical or environmental conditionsduring a time span; the method further comprising the step of CI)attaching said tag to said at least one constituent of said syringe; orthe step of CII) integrating at least a portion of said tag in aconstituent of said syringe; and wherein said tag comprises anelectronics unit comprising a control unit; a sensor unit comprising atleast one sensor for monitoring said physical or environmentalconditions; a display unit comprising a display for displaying datarelating to said integrity referred to as status data; a switch; whereinsaid control unit is structured and configured for effecting that saiddisplay unit displays said status data in reaction to an operation ofsaid switch.
 15. A method according to claim 14, comprising the step ofmanufacturing a unitary or an integrally formed part which establishessaid constituent of the syringe and an openable housing for at least apart of the tag.
 16. A method for monitoring an integrity of apharmaceutical product, the method comprising the steps of a) providinga syringe; b) providing I) an electronic tag attached at or to aconstituent of said syringe; or II) an electronic tag at least a portionof which is integrated in a constituent of said syringe; said syringecomprising a barrel, said barrel containing said pharmaceutical product;said tag being a tag for obtaining information relating to the integrityof said product as assessed from an exposure of said product to physicalor environmental conditions during a time span, the tag comprising anelectronics unit comprising a control unit; a sensor unit comprising atleast one sensor for monitoring said physical or environmentalconditions; a display unit comprising a display for displaying datarelating to said integrity referred to as status data; a switch; whereinsaid control unit is structured and configured for effecting that saiddisplay unit displays said status data in reaction to an operation ofsaid switch.
 17. The package according to claim 9, wherein a breaking ofsaid breakable electrical connection indicates the end of said time spanor the beginning of said time span.
 18. The package according to claim1, wherein said data is encoded in one or more of the color of the lightpulses; a duration of the light pulses; the number of the light pulsesin the sequence.